Life Following Excision of Neuroendocrine Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
Neuroendocrine tumors (NETs), often seen as "chronic cancer" present a survival paradox with relatively prolonged patient survival despite active disease. Treatment strategies emphasize management over cure, integrating tumor control with quality of life (QOL) considerations. Surgery is a cornerstone of NET management but demands a careful balance between its potential benefits and the morbidity risks. Current literature on post-surgical QOL is limited and non-generalizable, underscoring the need for comprehensive, multi-institutional data to inform surgical decisions.
We will study QOL after surgery for NETs in a prospective multi-institutional international cohort study. Specifically, we aim to 1) describe the post-operative QOL of patients with NETs and 2) identify factors associated with QOL measures after surgery for NETs. This project will be led in partnership by the Susan Leslie Clinic for NETs at Sunnybrook Health Sciences Centre in Toronto, Canada, and the IRCCS San Raffaele ENETS Centre of Excellent in Milan, Italy, and enrol adults undergoing surgery for resection of gastro-entero-pancreatic NETs across 12 North-American and European high-volume NETs surgery centres over a 18-month period. Measures of QOL using the SF-12 Survey, the EORTC-QLQ C30 and GEPNET21 tool, and clinical symptoms assessment, will be captured prior to surgery and at 6, 12, 24, and 36 months after surgery. Mixed linear regression models with random intercepts to account for longitudinal data correlation and individual variability will be used to analyze the QOL measures over time. Patient and service users engagement (PSUE) will be integrated throughout the study continuum.
This project will fill the knowledge gap in QOL after surgery for NETs, with a view to support better-informed surgical decisions and patient-centred care. The prospective, multi-institutional, and international design promises a comprehensive understanding of the impact of surgery on patient's lives, potentially shaping management pathways globally.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years old
Diagnosis of well-differentiated grade 1 to 3 NETs via histopathology (biopsy) or imaging (measurable tumor on CT or MRI with avidity on SSTR-PET scan).
Consents to surgery for resection of localized, loco-regional, or metastatic gastro-enteric (midgut) and pancreatic neuroendocrine tumor (GEP-NET).
Disqualifiers
Pre-operative diagnosis of neuroendocrine carcinoma on histopathology (biopsy) or imaging (measurable tumor on CT or MRI with avidity on FDG-PET scan and no avidity on SSTR-PET scan).
Declines surgery.
Unable to respond to study questionnaires (not proficient in local language).
Trial population
Patients undergoing surgery for resection of gastro-entero-pancreatic neuroendocrine tumors.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
246 Participants
are grouped into 1 trial groupGroup A: Resected GEP-NETs
Trial outcomes
Primary outcomes
1
Quality of life
Quality of life will be measured by the 12-item short-form quality of life survey (SF-12). The SF-12 is a validated tool that evaluates limitations in physical, social, and work activities due to physical or emotional problems to provide a measure of functional health and wellbeing. It evaluates 8 domains of quality of life: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. This survey has been tested both in the general population and in a variety of diseases, and is able to reflect changes in quality of life over time. Two composite scores are obtained from answers to the SF-12: the physical composite score (PCS) and the mental composite score (MCS). Average PCS and MCS for the general population are 50 points each with a standard deviation of 10 points. The SF-12 score goes from 0 to 100, with higher scores indicating better performance.
Time frame
Within 30 days before surgery (pre-operative) and at 6, 12, 24 and 36 months after surgeryOther outcomes
1
Self-reported patient symptoms
Patients' description of their symptoms will also be recorded at the pre-operative visit and re-examined and tracked at each follow-up assessment as improved, unchanged, or worsened as per patients' assessment.
Time frame
6, 12, 24 and 36 months after surgery2
QoL questionnaire EORTC-QLQ C30
The EORTC-QLQ C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) is a validated tool for use in patients with cancer and is widely used and accepted in cancer research. The GEPNET21 is a supplement to the QLQ-C30 which asks specific NET questions and has been validated in patients with NETs. It is recommended that both be used together. Using a linear transformation to standardise the raw score, the scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms
Time frame
within 30 days of surgery and at 6, 12, 24 and 36 months after surgerySponsors and contacts
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Source ClinicalTrials.gov